PMA P950039S035
- Device
- THINPREP PROCESSOR,
- Applicant
- Hologic, Inc.
- PMA number
- P950039
- Supplement
- S035
- Product code
- MKQ
- Decision date
- 2016-10-26
- Classification
- Processor, Cervical Cytology Slide, Automated
- Generic name
- Processor, cervical cytology slide, automated
- Approval order statement
- Approval of labeling changes for the ThinPrep® 3000 Processor.
Current openFDA PMA Record#
- Device
- THINPREP PROCESSOR,
- Applicant
- Hologic, Inc.
- PMA number
- P950039
- Supplement
- S035
- Product code
- MKQ
- Generic name
- Processor, cervical cytology slide, automated
- Decision date
- 2016-10-26
- Decision code
- APPR
- Date received
- 2016-10-05
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval of labeling changes for the ThinPrep® 3000 Processor.